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FDA Grants EUAs for Audere SARS-CoV-2 Sample Collection Kit, LGC Biosearch Tech COVID-19 Test

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a SARS-CoV-2 testing sample collection kit developed by Audere and a PCR-based SARS-CoV-2 test from LGC Biosearch Technologies.

Audere's HealthPulse@home Fusion collection kit is designed for the self-collection of anterior nasal swab specimens, either at home or in a healthcare setting, for molecular diagnostic testing at Audere-designated labs that are CLIA-certified to perform high-complexity tests.

In late 2021, Seattle-based Audere received EUA from the FDA for a similar COVID-19 testing specimen collection kit.

The Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test is designed to detect SARS-CoV-2 nucleic acid in anterior nasal swab specimens collected by a healthcare provider or self-collected under a healthcare provider's supervision. It is also authorized for use with samples collected using the HealthPulse@home Fusion kit.

Use of the test is limited to labs CLIA-certified to perform high-complexity tests, according to the FDA.

About a year ago, LGC Biosearch Technologies, the genomics division of UK-based LGC, received EUA from the FDA for another PCR-based COVID-19 test.